In particular, Brian's practice includes the interrelation between patent law and food and drug law. Brian's regulatory experience includes all types of FDA-regulated products: drugs and biologics (including animal drugs and biologics), medical devices, foods and dietary supplements, tobacco products, and cosmetics. Brian's intellectual property experience includes FDA and patent litigation for both innovator and generic companies, as well as patent prosecution for life science companies.

Awards & Recognitions

Client Work

Worked with innovator drug companies to develop strategies for approval of new drug applications (NDAs), including those filed as 505(b)(2) NDAs and biologics license applications (BLAs) (including biosimilar products filed as 351(k) applications. The approval strategies included developing clinical strategies, pre-investigational new drug applications (INDs) and pre-NDA/pre-BLA FDA meetings.

Analyzed, recommended, and prosecuted patents to build patent portfolios, including patents for listing in FDA's list of approved NDAs (Approved Drug Products with Therapeutic Equivalence Evaluations, also known as "the Orange Book").

Worked with innovator companies to develop risk management programs, including risk evaluation and mitigation strategies (REMS), some with elements to assure safe use (ETASU), to help mitigate risks. Worked with innovator drug companies to bring over-the-counter (OTC) drugs to market, such as OTC drugs based on FDA monographs or prescription-to-OTC NDA, which includes developing clinical plans for demonstrating the ability of the general public to effectively diagnose and treat their conditions with OTC drug products.

Worked with generic drug companies to conduct a pre-litigation analysis of the Orange Book-listed patents and expected approval requirements to develop a regulatory strategy for approval, including noninfringement strategies and patent invalidity or unenforceability arguments.

Worked with biosimilar (also known as follow-on biologics) applicants to develop clinical trial strategies for approval, which included considering biosimilar approvals in other countries, such as possible 505(b)(2) NDA approval strategies for certain products.

Medical Devices: Premarket

Assisted companies to register their medical device establishments and other licenses with FDA.

Worked with medical device companies to determine the appropriate classification for their proposed devices, including assisting with their 510(k) clearances and premarket approval applications (PMAs).

Worked with companies with laboratory developed tests (LDTs) to identify appropriate regulatory mechanisms to consider for continued product marketing and use in view of FDA's proposed regulatory program.

Worked with medical device companies to develop clinical trial programs for 510(k) clearances and PMAs, including investigational device exemptions (IDEs).

Worked with companies to develop strategies for approval of combination drug/device and combination drug products, including clinical programs, for example, an artificial pancreas incorporating marketed glucose monitors and insulin pumps and smartphone applications and algorithms, in view of FDA's mobile medical application and information technology guidance.

Worked with companies to develop appropriate medical device labeling, including for reuse or repackaged products.

Drugs/Biologics/Medical Devices: Regulatory Review

Worked with innovator companies to address clinical holds placed on their INDs or IDEs and overcome otherwise stalled product development plans.

Worked with innovator companies to develop proprietary names, including addressing concerns by FDA's Division of Medication Error Prevention and Analysis (DMEPA).

Worked with innovator companies to help them understand and participate in the advisory committee process and other public meetings for new product development and other issues, including using information from advisory committee meetings to assist in regulatory approval or lifecycle management strategies.

Worked with innovator companies to develop drug labeling that included claims in patents, risk management strategies, or other critical safety or effectiveness elements for marketing and approval.

Reviewed formulations (ingredients) for FDA compliance and proposed labeling for new cosmetic products, including making recommended labeling changes to avoid regulatory actions such as potential-drug-versus-cosmetic claims.

Tobacco Products

Reviewed tobacco product portfolios for tobacco product companies and made recommendations for compliance with the Family Smoking Prevention and Tobacco Control Act, including addressing import/export issues.

Reviewed advertising and promotion material for marketed products, including reviews by the Division of Prescription Drug Promotion (OPDP) to address agency concerns or raise arguments for innovator or generic companies in ANDA litigations with regard to the listing or assertion of method-of-use patents.

Worked with companies to address development and conduct of post market studies, including product recalls, discontinuations, or withdrawals.

Worked with companies to promote alignment with good clinical practices (GCPs) and manufacturing practices (GMPs) and address potential clinical hold or recall situations.

Worked with companies to address observations and recommendations made in FDA inspections, including developing corrective action plans and audits

Worked with companies to address FDA untitled or warning letters including drafting responses and discussing resolution agreements with FDA officials.

Worked with companies to develop strategies for FDA administrative proceedings, including filing or responding to citizen petitions and challenging FDA review division decisions prior to filing legal actions against the FDA.

Represented companies in lawsuits against FDA for arbitrary and capricious actions, including evaluating whether to bring such actions.

Worked with innovator companies to file patent term restoration applications with the US Patent and Trademark Office and to consider other possible patent-term adjustments or extensions.

Worked with companies to license their patent technologies and new product applications and develop product development partnerships.

Conducted due diligence investigations for patents, regulatory approvals and licensing agreements for companies seeking to acquire new products or companies, including research and development agreements that were part of settlement agreements. Most of these investigations resulted in formal due diligence reports and recommendations.

Developed regulatory and patent portfolio strategies and presentations for sales of products or companies to potential buyers and their counsel following audit of regulatory and intellectual property due diligence documents.

Provided regulatory litigation support for patent infringement litigations, including reviewing status of product approvals and regulatory requirements (including guidance documents), developing expert reports and litigation documents for stays and other actions, and otherwise integrating the patent litigation and regulatory strategies.

Represented Paddock Laboratories, Inc., for filing an ANDA for a generic form of Loprox® gel (ciclopirox) in Medicis Pharm. Corp. and Sanofi-Aventis Deutschland GmbH v. Paddock Laboratories, Inc. (D.MN. 06-2588). Medicis and Sanofi settled with Paddock prior to discovery based on the pleadings.

Advised Par Pharmaceutical Inc. regarding a method to sort data for complex compositions, including biologics without the need for a reference standard (US Patent No. 7,246,020: System and Method for Sorting Data).out the need for a reference standard (US Patent No. 7,246,020: System and Method for Sorting Data).

Previous Work

Immediately prior to law school, Brian worked as a legislative correspondent in the US Senate Committee on Labor and Human Resources. He began his legal career as a regulatory counsel at the US Food and Drug Administration, where he worked for more than nine years in both the Office of the Commissioner and the Center for Drug Evaluation and Research. At FDA, he focused on new product evaluations, compliance issues related to clinical investigations and intellectual property (e.g., patent term restoration). Brian's work resulted in new product approvals as well as new industry guidance documents and policies, such as the animal efficacy rule for counter-terrorism products. Following several years of practice in an FDA law firm, Brian returned to university to obtain a Bachelor of Science degree in biochemistry. Since then, Brian has had a hybrid practice, focusing on FDA and intellectual property law, in a law firm environment with a business focus for life science companies.

Professional Activities

Brian has been actively involved in promoting the biotechnology community locally, nationally and internationally. Locally, Brian is working with BioBuzz to help stimulate a more active bioscience workforce and a more dynamic bioscience industry throughout Maryland, Virginia, the District of Columbia and beyond. Brian has worked with the Montgomery County Department of Economic Development to present a program on "Innovative Strategies for New Product Development" and has been involved in the Biomanufacturing Technology Summit (biosimilars) sponsored by the Institute for Bioscience and Biotechnology Research (IBBR) at the University of Maryland. In addition, Brian has served on a board of judges for local entrepreneur contests at the University of Maryland's Mtech Biotechnology Research and Education Program and had been featured as a guest lecturer: "Entrepreneurship for Life Sciences Lessons in Start-Ups for Life Sciences Innovation". He also currently mentors several health law students through a program coordinated by the Maryland State Bar Association's health law group. Nationally and internationally, Brian has worked with life science companies to promote new and innovative technologies, including emerging growth companies.

In addition to his commitment to the life science community, Brian has also been elected to a variety of premier editorial board and bar association leadership roles. Some of these include:

Member, Advisory Board of Global Bioethics Initiative

Co-chair, NYSBA Committee on Cannabis Law

Chair, Food, Drug and Cosmetic Law Section of the New York State Bar Association

Advisory Board Member, Rare Disease Report

Editorial Board Member, FDAnews

Member, Board of Trustees, The Harbor School (pre-K to 2nd grade school in Bethesda, Maryland)

Member, New York State Bar Association's Committee on Legislative Policy

Member, New York State Bar Association's Non-Resident Committee

Member, New York State Bar Association's Committee on Continuing Legal Education

Member, New York State Bar Association's Committee on State Legislative Policy

Member, New York State Bar Association's Committee on Federal Legislative Priorities

Publications, Presentations & Recognitions

Given his particular experiences, Brian frequently is asked to speak and write on numerous FDA- and intellectual-property-law issues, including clinical trials and new product development for complex and challenging products, such as biotechnology products, orphan drugs, generic drugs, 505(b)(2) new drug applications, patent-term restoration under the Hatch-Waxman Act, biosimilar products, tobacco products, patent-term adjustment, risk management, and due diligence.

Brian has presented a variety of programs for a Korea-Maryland USA Bio Expo in Rockville, Maryland, on the following topics: (1) current good manufacturing practice (cGMP) and its role in regulatory drug quality, (2) current drug shortages and orphan drug disease pharmaceutical development, (3) innovative strategies for new drug development/biobetters; and (4) dietary supplements and functional foods. Brian's publications include:

Moderator, “Deconstructing the New Guidance on Expanded Access and Update on Legal Developments,” Expanded Access: FDA's New Regulatory Process How Compassionate Use Fits into Proposed Reforms, October 13, 2016

Speaker, “The Impact of the Evolving US Biosimilar Regulatory Policies on Bringing Biosimilars to Market," CBI 11th Summit on Biosimilars, January 29, 2016

Moderator, “FDA Update - Recent Developments and New Initiatives Including a MDUFA Update" and "Off-Label Promotion in the Wake of the Amarin Decision," 7th Annual Medical Device and Life Sciences Conference, November 19, 2015

Moderator, “Amarin and the Future of Off-Label Promotion," FDLI, November 16, 2015

Co-Speaker, “Regulations - The Good, the Bad, and the Ugly," Food Safety Challenges in an Era of Change: How to Better Protect Your Food and Beverage Company, Your Customers, and Yourself, October 9, 2014

Moderator, “Issues Concerning Development of Rare Disease and Special Population Medical Devices," AdvaMed 2014 The MedTech Conference, October 7, 2014

Panelist, “The Case for Small Markets with Large Returns: Orphans/Rare Disease Panel," Life Science Nation: Redefining Early Stage Investments, September 17, 2014

Speaker, “FDA Regulation: The Intersection of Policy and Politics, The Opportunities and Challenges for Innovation - Perspectives from Two Former FDEA Officials," New York State Bar Association Food, Drug and Cosmetic Law Section Annual Meeting, January 30, 2014

Footer

At Arent Fox, opportunity is a function of creativity, drive, and talent. You won’t find a top-down management structure setting the tone at our firm. Because we’re not a corporation, we’re a partnership. You’re in the driver’s seat. Let’s go.